VERAP Tablets 40 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-05-2024
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Active ingredient:
VERAPAMIL HYDROCHLORIDE
Available from:
Rowex Ltd
Dosage:
40 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2001-10-05
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0711/016/001
Case No: 2023417
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROWEX LTD
BANTRY, CO. CORK, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
VERAP 40 MILLIGRAM TABLETS
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 05/10/2006.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/10/2006_
_CRN 2023417_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Verap 40mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains verapamil hydrochloride 40.00 mg.
Excipient: Each tablet contains lactose monohydrate 22.0 mg
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex, film-coated tablet with a score notch. The score notch is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VERAP Tablets are indicated for the treatment of angina pectoris including Prinzmetal angina, supraventricular
tachycardia and mild to moderate essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Route
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